Promoting high-quality pain treatment trials through mentorship of junior investigators: A focus on study conduct and method development

通过初级研究者的指导促进高质量的疼痛治疗试验：关注研究行为和方法开发

• 批准号: 10436556
• 负责人: Jennifer Gewandter
• 金额: $ 30.58万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10436556
• 关键词: Accelerometer; Address; Adult; Affect; Analgesics; Chemotherapy-induced peripheral neuropathy; Chronic low back pain; Clinical; Clinical Trials; Communities; Conduct Clinical Trials; Data; Data Analyses; Data Collection; Development; Documentation; Ensure; Environment; Equilibrium; Esthesia; Family member; Friends; Funding; Goals; Grant; Individual; Industry; Infrastructure; Injections; Intermittent Claudication; Lower Extremity; Manuscripts; Measures; Mentors; Mentorship; Methods; Monitor; Neuropathy; Opioid Analgesics; Outcome; Outcome Measure; Pain; Pain Research; Pain management; Pain quality; Patient Outcomes Assessments; Patient Self-Report; Patients; Pattern; Performance; Phase; Phase II Clinical Trials; Phenotype; Principal Investigator; Prospective cohort study; Publications; Publishing; Randomized Clinical Trials; Research; Research Methodology; Research Personnel; Research Project Grants; Risk; Sciatica; Site; Steroids; Syndrome; Testing; Time; Training; Transcutaneous Electric Nerve Stimulation; Treatment Side Effects; United States National Institutes of Health; Universities; Validity and Reliability; Visit; addiction; base; career; chronic pain; chronic painful condition; clinical center; clinical investigation; clinical pain; clinically relevant; community based research; conditioned pain modulation; design; drug development; educational atmosphere; effective therapy; experience; faculty research; faculty support; functional status; improved; knowledge base; meetings; method development; novel; novel marker; novel therapeutics; opioid epidemic; patient variability; peer coaching; primary outcome; programs; recruit; research study; secondary analysis; side effect; skills; success; tool; tool development; training opportunity; treatment trial

PROJECT SUMMARY / ABSTRACT Chronic pain impacts 20-30% of U.S. adults. Unfortunately, available pain treatments tend to be only moderately effective at best and many individuals cannot tolerate the associated adverse side effects. The use of opioid analgesics for treatment of chronic pain contributed, at least in part, to the current opioid crisis, affecting both individuals with pain and their family members and friends, and highlighting the need for the development of novel, non-addictive pain therapies. The NIH responded to this need by emphasizing the importance of high- quality clinical trials that incorporate novel biomarkers and endpoints in order to promote the development of effective pain therapies. To drive this effort, the NIH established the Early Phase Pain Investigation Clinical Network (EPPIC-Net) to provide a robust and readily accessible knowledgeable community and infrastructure for rapid design and performance of phase II clinical trials of pain treatments. The PI of this application is the MPI of the University of Rochester EPPIC-Net Specialized Clinical Center (UR EPPIC-Net), providing a unique opportunity to train mentees in the conduct of multisite pain clinical trials. Furthermore, the PI’s ongoing program of research addresses the need for condition-specific, clinically-meaningful outcome measures for pain trials and synergizes with EPPIC-Net efforts to (1) make valuable contributions to the field of clinical pain research and (2) offer a range of training opportunities in clinical pain research. The overall goal of this K24 proposal is to provide mentoring and research opportunities for junior investigators in order to increase the number of skilled clinical pain researchers who can design, conduct, analyze, and disseminate results of high-quality pain clinical trials, and in turn accelerate the development of novel therapies for chronic pain. Aim 1 will leverage the UR EPPIC- Net to train researchers on the necessary skills to conduct high-quality clinical trials for chronic pain therapies. Aims 2 and 3 are research projects focused on developing tools to improve clinical trials for 2 chronic pain conditions for which few effective therapies exist (i.e., chemotherapy-induced peripheral neuropathy (CIPN) and neurogenic intermittent claudication (NIC), a phenotypically-distinct, neuropathic chronic low back pain syndrome). Specifically, Aim 2 investigates the reliability and validity of measures of balance, lower limb sensation, and conditioned pain modulation for evaluating functional status or characterizing pain mechanisms in patients with CIPN. Aim 3 investigates the validity of clinically-relevant, accelerometry-based outcomes for NIC. Both of these aims leverage data from the PI’s current projects, providing efficient and valuable opportunities for the PI’s mentees to gain experience with data analyses, interpretation, and dissemination of clinical pain research findings via manuscripts and presentations. The K24 proposal outlines the PI’s plan for a highly collaborative and supportive research environment.

项目摘要 /摘要 慢性疼痛影响20-30％的美国成年人。不幸的是，可用的疼痛治疗往往只是中等 充其量有效，许多人无法忍受相关的不良副作用。使用OOID 治疗慢性疼痛的镇痛药至少部分造成了当前的阿片类药物危机，两者都影响 有痛苦的人以及他们的家人和朋友，并强调了发展的需求 新颖的，非成瘾性疼痛疗法。 NIH通过强调高级的重要性来应对这种需求 优质的临床试验结合了新型生物标志物和终点，以促进 有效的疼痛疗法。为了推动这项工作，NIH建立了早期疼痛调查临床 网络（EPPIC-NET）提供一个稳健且易于访问的知识渊博的社区和基础架构 用于疼痛治疗的II期临床试验的快速设计和性能。此应用程序的PI是 罗切斯特大学Eppic-Net专业临床中心（Ur Eppic-NET）的MPI，提供了独特的 有机会训练月经进行多站点疼痛临床试验的机会。此外，PI的正在进行的计划 研究解决了针对疼痛试验的特定条件，临床上敏锐的结果指标的需求 与Eppic-Net的努力协同（1）为临床疼痛研究领域做出宝贵贡献和（2） 在临床疼痛研究中提供一系列培训机会。此K24提案的总体目标是提供 初级研究人员的指导和研究机会，以增加熟练的临床数量 可以设计，进行，分析和传播高质量疼痛临床试验结果的疼痛研究人员， 反过来，加速了新型慢性疼痛疗法的发展。 AIM 1将利用您的Eppic- 网络以培训研究人员有关进行慢性疼痛疗法的高质量临床试验的必要技能。 目标2和3是研究项目，专注于开发工具以改善2种慢性疼痛的临床试验 几乎没有有效疗法的疾病（即化学疗法诱导的周围神经病（CIPN）和 神经源性间歇性lau不平（NIC），一种表型染色的神经性慢性腰痛 综合征）。特别是AIM 2研究了平衡度量的可靠性和有效性，下肢 感觉和调节疼痛调节，以评估功能状态或表征疼痛机制 在CIPN患者中。 AIM 3研究了基于临床上的，基于加速度计的结果的有效性 NIC。这两个目标都利用PI当前项目的数据，提供高效且有价值 PI月经有机会获得数据分析，解释和传播的经验 临床疼痛研究结果通过手稿和演示文稿。 K24提案概述了PI的计划 高度协作和支持性的研究环境。

项目成果

Identifying participants' preferences for modifiable chemotherapy-induced peripheral neuropathy prevention clinical trial factors: an adaptive choice-based conjoint analysis.

• DOI: 10.1007/s00520-022-07447-y
• 发表时间: 2022-12
• 期刊: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

Expectations for Improvement: A Neglected but Potentially Important Covariate or Moderator for Chronic Pain Clinical Trials.

改善的期望：慢性疼痛临床试验中被忽视但可能重要的协变量或调节因素。

• DOI: 10.1016/j.jpain.2022.12.011
• 发表时间: 2023
• 期刊: The journal of pain
• 作者: Langford,DaleJ;Lou,Raissa;Sheen,Soun;Amtmann,Dagmar;Colloca,Luana;Edwards,RobertR;Farrar,JohnT;Katz,NathanielP;McDermott,MichaelP;Reeve,BryceB;Wasan,AjayD;Turk,DennisC;Dworkin,RobertH;Gewandter,JenniferS
• 通讯作者: Gewandter,JenniferS